Hydroxychloroquine for Japanese patients with rheumatoid arthritis

JRCT ID: jRCTs031180050

Registered date:07/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 26/12/2017
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Treatment with hydroxychloroquine for 24 weeks

Outcome(s)

• Primary Outcome: Achievement rate of ACR20 at week 24

Secondary Outcome

Achievement rate of improving DAS28 category at weeks 4, 8, 12 and 24
Achievement rate of low disease activity in DAS 28 at weeks 4, 8, 12 and 24
Achievement rate of clinical remission in DAS 28 at weeks 4, 8, 12 and 24
Achievement rate of functional remission in HAQ at weeks 4, 8, 12 and 24
Achievement rate of structural remission in modified total Sharp score at week 24
Achievement rate of ACR 20 at at weeks 4, 8, and 12
Achievement rate of ACR 50/70 at weeks 4, 8, 12 and 24
Adverse effects during whole study

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Rheumatoid arthritis patients with active disease (DAS28 greater than or equal to 2.6) over 18 years old
• Exclude criteria: Contraindication to HCQ, e.g. history of retinopathy and hypersensitivity to 4-aminoquinoline

Related Information

• Primary Sponsor: Kaneko Yuko
• Source(s) of Monetary Support: Sanofi K.K.
• Secondary ID(s): UMIN000023989